[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100620394":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":11,"centralContacts":39,"locations":45,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":11,"overallStatus":48,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Joincare Pharmaceutical Group Industry Co., Ltd","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"JKN2301 + Oseltamivir Placebo","EXPERIMENTAL",null,[13,14],"Drug: JKN2301 Dry Suspension","Drug: Oseltamivir Placebo",{"label":16,"type":17,"description":11,"interventionNames":18},"Oseltamivir + JKN2301 Placebo","ACTIVE_COMPARATOR",[19,20],"Drug: Oseltamivir","Drug: JKN2301 Placebo",[22,27,31,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","JKN2301 Dry Suspension","Single oral dose, administered according to a weight-tiered dosing scheme.",[9],{"type":23,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"Oseltamivir Placebo","Oral suspension, administered twice daily for 5 days, matched to the weight-based dosing of active oseltamivir.",[9],{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"Oseltamivir","Oral suspension, administered twice daily for 5 days according to the approved weight-based dosing regimen.",[16],{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":11},"JKN2301 Placebo","Single oral dose, matched to the weight-tiered dosing scheme of active JKN2301.",[16],[40],{"name":41,"role":42,"phone":43,"phoneExt":11,"email":44},"Ying Yang","CONTACT","+86-0755-33268688","overseas@joincare.com",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":11},"First Affiliated Hospital of Guangzhou Medical University","RECRUITING","Guangzhou","Guangdong","510000","China","CN",{"type":55,"coordinates":56},"Point",[57,58],113.25,23.11667,{"lat":58,"lon":57},{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100620394","phase-3-phase-iii-clinical-study-evaluating-the-safety-pharmacokinetics-and-efficacy-of-jkn2301-dry-suspension-in-pediatric-patients-aged-2-to-under-12-years-with-influenza-100620394",false,"NCT07357051","Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza","A Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Phase III Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of JKN2301 Dry Suspension in Pediatric Patients Aged 2 to Under 12 Years With Influenza","Inclusion Criteria:\n\n* Pediatric patients within the specified age range.\n* Clinical presentation consistent with influenza, confirmed by a positive local rapid test or central laboratory PCR test.\n* Presentation for treatment within the early symptomatic phase of influenza illness.\n* Presence of fever and at least one respiratory symptom.\n* Ability to swallow oral suspension.\n* Parent\u002Fguardian and patient (as age-appropriate) able to provide informed consent\u002Fassent.\n\nExclusion Criteria:\n\n* Clinical signs suggestive of severe or complicated influenza infection\n* requiring inpatient management.\n* Presence of a concurrent bacterial infection requiring systemic therapy.\n* Significant immunocompromised, or severe\u002Funcontrolled comorbid conditions.\n* History of hypersensitivity to any component of the investigational products.\n* Use of prohibited medications (including other anti-influenza antivirals) within a specified period prior to enrollment.\n* Recent participation in another interventional clinical trial.\n* Any condition that, in the opinion of the investigator, would jeopardize patient safety or compliance with the study protocol.","ALL","2 Years","11 Years",{"count":73,"type":74},177,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","The goal of this phase III study is to learn if JKN2301 Dry Suspension works to treat uncomplicated influenza in Pediatric Participants aged 2 to 11 years.",[80],"Respiratory Viral Infection","2026-01-15",{"date":83,"type":84},"2026-01-21","ACTUAL",{"date":86,"type":84},"2025-11-07",{"date":88,"type":74},"2026-04-15",{"name":5,"class":6},1]